SUI is the sudden involuntary loss of urine that occurs due to a rise in intra-abdominal pressure. Those who suffer from SUI commonly experience such urine loss during a variety of heightened-stress activities such as laughing, sneezing, or common exercise.
When supported by healthy pelvic floor muscles and strong connective tissue, the urethra is able to maintain a fluid seal and, thus, prevent the involuntary loss of urine during physical stress. When a patient suffers from SUI, weakened pelvic muscle and connective tissue are unable to support the urethra in its natural position. These muscles and tissues are commonly weakened as a result of activities such as vaginal childbirth, and their degradation may be exacerbated by the estrogen loss that accompanies menopause. As a result, as pressure is exerted on the bladder, the urethra cannot remain closed and urine may escape.
Conventional treatments for SUI include the use of diapers, pelvic muscle exercises, biofeedback, medication, and hormone therapy. A wide variety of surgical operations may also be used to correct this condition. Such operations generally involve elevating the bladder neck anteriorly and often include elongating, narrowing, and/or supporting the proximal portion of the urethra.
One type of surgical operation used to correct SUI is the transvaginal tape (“TVT”) procedure. The TVT procedure uses a medical device, such as a length of tape or mesh, to reinforce and support the urethra. In such a procedure, the mesh may be surgically implanted in the body of the patient and may be positioned so as to provide support to the urethra when needed, such as in situations of stress. The mesh may be inserted through a small incision in the vagina. The mesh may then be fed distally through the patient's pelvic tissue and positioned beneath the urethra.
Depending on the condition of the patient, it may be desirable to round or dull the edges of a portion of the mesh. Dulling the edges of the mesh may minimize irritation to the urethra after the mesh has been implanted within the body of the patient and may minimize the erosion of urethra cells caused by movement of the mesh relative to the urethra. Existing devices, however, may not enable a physician to locate or position the dulled portion of a mesh while surgically implanting the mesh within the body of the patient.
As shown in FIG. 13, Boston Scientific Corporation's Advantage TM Mid-Urethral Sling System consists of a mesh 10 disposed within sleeve 15. This system includes a centering tab 500 to locate the dulled portion 45 of the mesh 10 while the mesh 10 is disposed within the sleeve 15, and controllably position the dulled portion 45 of the mesh 10 relative to the urethra when implanting the mesh 10 within the body of the patient. The centering tab 500 has a channel 25 that accepts a portion of the sleeve 15 proximate the dulled portion of the mesh 10. The sleeve 15 is fixed to the centering tab 500 through a heat seal at an end of the tab 500. The centering tab 500 includes a through hole 50 next to the seal. The portion of the sleeve 15 disposed within the channel 25 may be visible through the through hole 50.
As FIG. 14 illustrates, once the mesh 10 has been positioned within the patient, the centering tab 500 and the sleeve 15 may be cut into two pieces to assist in removing the assembly 6 (other than the mesh 10) from the body of the patient. Since the sleeve 15 is coupled to the centering tab 500 proximal the through hole 50, the through hole 50 may be useful in determining an appropriate location to sever the centering tab 500. For example, severing the centering tab 500 along the through hole 50 will sever the sleeve 15 and enable the physician to remove the assembly 6 (other than the mesh 10) from the patient's body.
Cutting the centering tab 500 into two pieces, however, results in an additional, small assembly piece 8 that must be removed from the body of the patient. In addition, the small pieces of centering tab 500 may be more difficult to grasp and/or remove from the patient's body after being severed.
The present disclosure provides assemblies for positioning medical devices that avoid some of the aforementioned shortcomings of existing assemblies.